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All product recalls associated with Gentherm Medical, LLC.
Total Recalls
2
Past Year
0
Class I (Serious)
0
Most Recent
Nov 2021
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surgery which could lead to patient infection.